Federal Circuit Upholds Vanda Fanapt Personalized Method Claims Against Patent Eligibility Challenge

In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided panel of the Federal Circuit upheld Vanda’s personalized method of treatment claims relating to its Fanapt® (iloperidone) product against a patent eligibility challenge. Interestingly, where the district court had found the claims eligible at step two of the Mayo/Alice analytical framework, the Federal Circuit found them eligible at step one. Chief Judge Prost filed a dissenting opinion.

(The Federal Circuit addressed several important issues in its decision. This article focuses on patent eligibility.)

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Federal Circuit Finds Composition of Matter Ineligible For Patenting

In a non-precedential decision issued in In re Bhagat, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that claims directed to certain lipid compositions were ineligible for patenting under 35 USC § 101. Did the court do more or less harm by rendering its decision without much explanation?

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An Economic Test For Patent Eligibility?

In the non-precedential decision issued in Exergen Corp. v. Kaz USA, Inc., Judge Moore considered the time and money it took to develop the invention at issue when deciding that the claims satisfy the patent eligibility requirement of 35 U.S.C. § 101. While other patent eligibility decisions make clear that an inventor’s investment will not always be relevant, Exergen offers an interesting way to evaluate whether claim elements relate to more than “well-understood, routine and conventional” activity.

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USPTO Withdraws Newly Characterized Antigen Test For Written Description Of Antibodies

The USPTO issued a two page memorandum to the Patent Examining Corps noting that some of the USPTO’s written description guidance pertaining to antibody claims is “outdated.” The memo specifically notes withdrawal of the “newly characterized antigen test” for written description of antibodies, and advises that additional written description examination guidance is forthcoming.

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Are These INOMax Therapeutic Method Claims Directed To A Natural Phenomenon?

In Mallinckrodt Hospital Prods. IP Ltd. v. Praxair Distrib., Inc., Judge Sleet of the U.S. District Court for the District of Delaware invalidated personalized method of treatment claims under 35 USC § 101 as being directed to a natural phenomenon. If the Federal Circuit affirms the decision, will it leave room to draw a line that spares other methods of treatment?

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